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¡´Wednesday, December 6, 2017 - 7:30am Pfizerµo§GPhase 3 PALOMA-2 trial§ó¸Ô²Óªº¼Æ¾Ú

IBRANCE(palbociclib)+ letrozole vs. letrozole+placebo

¦bpostmenopausal women (ER+, HER2-)MBC(metastatic breast cancer)ªºªvÀø¤W

mPFS= 27.6 months [95% CI: 22.4, 30.3] vs 14.5 months [95% CI: 12.3, 17.1] (HR=0.56 [95% CI: 0.46, 0.69])

median follow-up>3¦~¡A¬OCDK 4/6 inhibitor¤¤°lÂ̤ܳ[ªº¬ã¨s¡I

¥H¤Wµ²ªG©M·íªìprimary analysis for PALOMA-2ªºµ²ªG¬O¤@­Pªº¡C·íªìªº¼Æ¾Ú

mPFS=24.8 months (95% CI: 22.1, NE) vs. 14.5 months (95% CI: 12.9, 17.1) (HR=0.58 [95% CI: 0.46,0.72], p<0.0001).

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¡§There currently is no cure for metastatic breast cancer, so prolonging progression-free survival and delaying the need for additional anticancer therapies are critical factors in treating these patients,¡¨ said Hope Rugo, MD, lead author and professor of medicine and director of Breast Oncology and Clinical Trials Education at the University of California San Francisco Helen Diller Family Comprehensive Cancer Center. ¡§The updated findings from PALOMA-2 provide additional evidence to support ¡´the use of palbociclib with an aromatase inhibitor as a standard of care in the first-line ¡´setting for postmenopausal patients with hormone receptor-positive (HR+), HER2- metastatic breast cancer across all patient subgroups.¡¨

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the most common adverse reactions (≥20%) of any grade

neutropenia (80% vs 6%), infections (60% vs 42%), leukopenia (39% vs 2%), fatigue (37% vs 28%), nausea (35% vs 26%), alopecia (33% vs 16%), stomatitis (30% vs 14%), diarrhea (26% vs 19%) and anemia (24% vs 9%).

¡´Friday, December 8, 2017 - 8:30am Pfizer¤Sµo§GPhase 3 EMBRACA trialªº¼Æ¾Ú

°w¹ïgermline (inherited) BRCA1/2-positive (gBRCA+)ªºMBC

BRCA1 and BRCA2 are human genes that produce proteins involved in DNA repair. 2,3,4 BRCA mutations can be hereditary (germline) or occur spontaneously (sporadic).

2 Together, BRCA1 and BRCA2 mutations¡÷20%~25% hereditary breast cancers & 5%~10% of all breast cancers.

65%¦³¿ò¶ÇBRCA mutationªº¤k©Ê will develop breast cancer by age 70.

¦³¿ò¶ÇBRCA mutationªº³q±`·|¤ñ¨S¦³¿ò¶Çªº¤k©Ê­n³Q¦­¶EÂ_¥X¨ÅÀù.

talazoparib vs. ¼Ð·Ç¤ÆÀøchemotherapy.

mPFS= 8.6 months (95% CI: 7.2, 9.3) vs. 5.6 months (95% CI: 4.2, 6.7) [HR: 0.54 (95% CI: 0.41, 0.71), p<0.0001]. ­°§C46% ¯e¯f´c¤Æ

ORR= 62.6% vs. 27.2% [OR: 4.99 (95% CI: 2.9-8.8), p<0.0001]).

¡´Talazoparib¬O¤fªAoral, Âù¾÷Âà§í¨îdual-mechanism poly ADP ribose polymerase (PARP) inhibitor , ¤@¤Ñ¦Y¤@Áû.

¡´¹ï¯E¹©¼vÅT³Ì¤jªºÀ³¸Ó¬O

EMBRACA trial ªºsubgroups¼Æ¾Ú¤]¬O¤@­Pªº¡I¡I¡I

triple negative [TNBC] or hormone receptor-positive [HR+], BRCA mutation (1 or 2), prior chemotherapy (¸g¹L¤@½uªvÀøor¬Æ¦Ü¸g¹L¤j©ó¤T½u¶Ê´Ý), ¦³ central nervous system (CNS) metastases.

¡´There also was a statistically significant delay in the time to clinically meaningful deterioration in global health status/quality of life with talazoparib versus chemotherapy (HR 0.38 [95% CI 0.26-0.55], p<0.0001), as measured by the EORTC QLQ-C30, a cancer-specific, patient-reported quality of life questionnaire.

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any grade=at least 15% of patients

anemia (52.8%), fatigue (50.3%), nausea (48.6%), neutropenia (34.6%), headache (32.5%), thrombocytopenia (26.9%), alopecia (25.2%), vomiting (24.8%), diarrhea (22%), constipation (22%), decreased appetite (21.3%), back pain (21%) and dyspnea (17.5%).

The incidence of serious AEs was 31.8% in the talazoparib arm and 29.4% in the chemotherapy arm.

¦]°Æ§@¥Î¦Ó²×¤îªº= 7.7% of patients in the talazoparib arm and 9.5% of patients in the chemotherapy arm.

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Phase III IMpower150 study showed Tecentriq (atezolizumab) and Avastin (bevacizumab) plus chemotherapy reduced the risk of disease worsening or death by 38 percent for people with a type of advanced lung cancer

• First Phase III combination trial of a cancer immunotherapy to show improvement in progression-free survival as an initial treatment in advanced non-squamous non-small-cell lung cancer (NSCLC)

Tecentriq+Avastin+carboplatin+paclitaxel vs. Avastin+carboplatin+paclitaxel

¤@½uªvÀøEGFR(-), ALK(-)ªºadvanced non-SCC (NSCLC)-----¬ù¦ûÁ`ªÍÀù¤H¤fªº20%~25%(30¸U¤H/¦~)

mPFS= 8.3 vs. 6.8 months (hazard ratio [HR]=0.62; p<0.0001 95 % CI: 0.52-0.74)

­°§C38%¯e¯f´c¤Æ©Î¦º¤`¡C

12-month PFS= 37% vs. 18%

ORR= 64 % vs. 48%

¦w¥þ©Ê¡÷ÁpÃÄ»P³æÃĬO¤@­Pªº¡A¨S¦³µo²{·sªº¦w¥þ°T®§

The safety profile of the Tecentriq and Avastin plus chemotherapy combination was consistent with the safety profiles of the individual medicines, and no new safety signals were identified with the combination

¦pªG¬O¦³T-effector gene expression Wild typeªºsubgroup

mPFS = 11.3 vs. 6.8 months (HR=0.51; p<0.0001 95% CI: 0.38-0.68)

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OSªº¼Æ¾Ú·|¦b2018¦~¤¤¤½§G¡C

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Go go Polaris!!!

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Position: C.E.O

Subject: Ãö©óFDAªºSPA(special protocol assessment)

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Best regards,

VP, Finance and Accounting

Polaris Group

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1. EGFR(10%~60%)¡÷1-L²Ä¤@¥N Iressa (AstraZeneca), 2-L/3-L²Ä¤G¥NTarceva (Roche), 1-L²Ä¤T¥N Tagrisso (AstraZeneca), ²Ä¥|¥NNorvatis§Ö¥X¨Ó¤F

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2. VEGF¡÷Avastin (Roche)ªº¤Ñ¤U(±M§Q¨ì´Á2019 July USA, 2022 Jan Europe)

3. ALK(5%)¡÷Xalkori(Pfizer)²Ä1¥N, Ceritinib (Norvatis) ²Ä2¥N, Brigatinib(¤é¥»ªZ¥Ð) ²Ä2¥N,Alectinib (Roche)1-L 2017/11/17

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Pembrolizumab Plus Epacadostat Alone or With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo in Metastatic Non-Small Cell Lung Cancer

NCT03322566

Estimated Enrollment: 1062

Anticipated Study Start Date: December 1, 2017

Estimated Study Completion Date: December 30, 2022

Estimated Primary Completion Date: October 26, 2022 (Final data collection date for primary outcome measure)

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Nivolumab and Epacadostat With Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Non-Small Cell Lung Cancer

NCT03348904

Estimated Enrollment: 630

Anticipated Study Start Date: December 2017

Estimated Study Completion Date: April 2022

Estimated Primary Completion Date: March 2021 (Final data collection date for primary outcome measure)

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CFIUS completes review of proposed merger of Bayer and MonsantoLeverkusen/St. Louis, December 1, 2017 ¡V Bayer and Monsanto (NYSE: MON) today announced that the Committee on Foreign Investment in the United States (¡§CFIUS¡¨) has completed its review of the proposed merger, and has concluded that there are no unresolved national security concerns with respect to the transaction.

The acquisition is subject to customary closing conditions, including receipt of required regulatory approvals. Bayer and Monsanto will continue to cooperate with the authorities in order to complete the transaction in early 2018.

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